Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

No test item related deaths occurred during the study period. The animals treated with the test item did not show any clinical signs during the course of the study. The substance showed skin sensitizing properties in the GPMT according to the current OECD guidelines. Therefore, the substance has to be classified as a skin sensitizer.


Migrated from Short description of key information:
The sensitization potential of the substance was investigated according to OECD Guideline 406. The test item concentrations chosen for the GPMT test were 1% and 50% for the intrcutaneous/epidermal induction and 15% for the challenge.

Justification for selection of skin sensitisation endpoint:
Guideline-conform study under GLP without deviations.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The substance showed skin sensitizing properties in the Guinea pig Maximization Test according to the current OECD guidelines. Therefore, the substance has to be classified as a skin sensitizer Cat. 1A (H317 - May cause an allergenic skin reaction) according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).